Colorectal NeoplasmsNCT06427109
Omega-3 Fatty Acid and Colorectal Adenoma
An observational study of Colorectal Neoplasms and Adenoma Colon, run by DongGuk University at 1 site in South Korea.
Trial summary
Patients aged >40 years who underwent elective colonoscopies were recruited from ten institutions. Patients with a history of colorectal cancer or long-term dietary interventions were excluded. Participants completed a food frequency questionnaire (FFQ) prior to endoscopy. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colorectal Neoplasms, Adenoma Colon
- What is being tested?
- Dietary intake of omega-3 fatty acid
- How many people
- 798 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2021to 21 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
Study population: Multi-center, nationwide cohort in Korea
Who may be able to join
- all patients aged more than 40 years of age, scheduled for elective colonoscopy.
Who cannot join
- inflammatory bowel diseases
- history of colorectal neoplasms
- prior gastrointestinal surgery
- substance abuse including alcohol
- an inability to complete the survey due to emergency endoscopy
- cognitive impairments and those undergoing significant dietary modifications
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi Province, 14353
About this study
Official title: Omega-3 Fatty Acid Intake and Risk of Colorectal Adenoma
Patients aged >40 years who underwent elective colonoscopies were recruited from ten institutions. Patients with a history of colorectal cancer or long-term dietary interventions were excluded. Participants completed a food frequency questionnaire (FFQ) prior to endoscopy. FFQ data were analyzed using energy-, age-, sex-, and body mass index-adjusted models; the dietary supplemental omega-3 intake was analyzed separately. Colonoscopy outcome data, including the adenoma number, pathology, and location, were collected. Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends using P for trend analysis.
- Conditions
- Colorectal Neoplasms, Adenoma Colon
- Being tested
- Dietary intake of omega-3 fatty acid
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intake of omega-3 fatty acidDietary supplement
Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Colorectal adenoma
among groups with different omega-3 intake levels
Measured: at the completion of the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Nov 2021
- Primary completion30 Nov 2023
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 798 participants (actual)
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Hoon Kim, Chung-Ang University
- Investigators
- Yun Jeong Lim, Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427109
- Sponsor's protocol ID
- O3FA
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acid Intake and Risk of Colorectal Adenoma
- ClinicalTrials.gov ID
- NCT06427109
- Acronym / sponsor ID
- O3FA
- Conditions
- Colorectal Neoplasms, Adenoma Colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 798 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients aged >40 years who underwent elective colonoscopies were recruited from ten institutions. Patients with a history of colorectal cancer or long-term dietary interventions were excluded. Participants completed a food frequency questionnaire (FFQ) prior to endoscopy. FFQ data were analyzed using energy-, age-, sex-, and body mass index-adjusted models; the dietary supplemental omega-3 intake was analyzed separately. Colonoscopy outcome data, including the adenoma number, pathology, and location, were collected. Participants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends using P for trend analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Multi-center, nationwide cohort in Korea
Key inclusion criteria (1 listed)
- all patients aged more than 40 years of age, scheduled for elective colonoscopy.
Key exclusion criteria (6 listed)
- inflammatory bowel diseases
- history of colorectal neoplasms
- prior gastrointestinal surgery
- substance abuse including alcohol
- an inability to complete the survey due to emergency endoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary intake of omega-3 fatty acidParticipants were stratified into omega-3 consumption quartiles to assess colorectal adenoma incidence trends | Dietary supplement | – |
Primary outcome
Incidence of Colorectal adenoma
Time frame: at the completion of the colonoscopy procedure
among groups with different omega-3 intake levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Jeong Lim principal investigator
DongGuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Adenoma Colon, run by DongGuk University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Colorectal adenoma (time frame: at the completion of the colonoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.